MIS-C Comparative Effectiveness Study
Summary
In March 2020, children exposed to the virus that causes the COVID-19 illness, SARS-CoV-2, presented with fever and significant inflammation about a month after exposure to the virus. Some children were sick enough to require care in the intensive care unit for what came to be known as Multisystem Inflammatory Syndrome-Children (MIS-C).The clinical presentation shared many features with Kawasaki disease (KD), a self-limited inflammation that can cause ballooning of the arteries of the heart. Thus, physicians reached for many of the therapies used to treat children with KD. Despite the surge of COVID-19 cases and children continuing to present with MIS-C, there are no data that guide the choice of therapy. Thus, the investigators have designed a study to determine which combination of therapies is most effective in helping children with MIS-C recover quickly.
Timeline
- Start
- 2020-12-22
- Primary completion
- 2023-12-22
- Completion
- 2024-04-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anakinra | Protein / enzyme biologic | 8 mg/kg | Intravenous |
| Comparator | Infliximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Comparator | Methylprednisolone | Other / unclassified | 2 mg/kg | Intravenous |